GAS RELIEF ULTRA STRENGTH- simethicone capsule, liquid filled 
Cardinal Health (Leader) 70000

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each softgel)

Simethicone 180 mg

Purpose

Antigas

Use

Warnings

Stop use and ask a doctor if

condition persists.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children.

Directions

Other information

Inactive ingredients

FD&C red #40*,FD&C yellow # 6, gelatin, glycerin

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO PHAZYME® ULTRA STRENGTH active ingredient†

Ultra Strength

Gas Relief

Simethicone, 180 mg | Antigas

Fast relief of:

Gas

Pressure

Bloating

Discomfort

SOFTGELS

**This product is not manufactured or distributed by C.B. Fleet Company Inc., distributor of Phazyme® Ultra Strength.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Package Label

Simethicone 180 mg

LEADER Ultra Strength Gas Relief

GAS RELIEF  ULTRA STRENGTH
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0566
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code 05A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0566-11 in 1 BOX05/29/2020
160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33205/29/2020
Labeler - Cardinal Health (Leader) 70000 (063997360)

Revised: 9/2021
Document Id: ed97da6a-3c59-4515-b4a1-43a5cbb916d5
Set id: 99fc8504-b9d8-4428-bae0-aa39b0d2183e
Version: 3
Effective Time: 20210928
 
Cardinal Health (Leader) 70000